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Checkbiotech: FDA to issue guidelines on evaluating biotech food
Posted by: DR. RAUPP & madora (IP Logged)
Date: November 26, 2004 09:53AM ;

The Food and Drug Administration will publish draft guidelines today that
would encourage companies to submit voluntary safety evaluations of
bioengineered food crops that sometimes drift and cross-pollinate with
plants in nearby fields. The biotech industry welcomed the new approach, but
environmental and food-safety advocates called it a poor substitute for the
rigorous testing they have sought before the planting of scientifically
engineered crops that could enter the nation's food supply, November 2004 by
Michael S. Rosenwald .

"This doesn't get us on the road to full mandatory testing, which is what
we've been saying is needed," said Joseph Mendelson III, the legal director
at the Center for Food Safety. "It's trying to put a Band-Aid on problems
that need a wholesale fix."

The current system encourages companies developing a bioengineered food crop
to consult with the FDA early in its development on possible scientific and
regulatory issues. Under the new FDA guidelines, which are to be published
today in the Federal Register, companies also would be asked to conduct a
voluntary safety evaluation and submit it to the agency.

Critics of bioengineered crops have called instead for full-scale, mandatory
safety testing and prohibiting the introduction of new biotech foods without
detailed FDA certification that they are safe.

FDA officials said the new, voluntary guidelines will give regulators a more
detailed and advanced understanding of bioengineered crops should they
become cross-pollinated with material entering the food supply.

The agency said in a statement that its policy is to encourage
"communication early in the development process for a new plant variety."
But the FDA added that it "has not found and does not believe that new plant
varieties under development for food and feed use generally pose any safety
or regulatory concerns."

Michael J. Phillips, a vice president with the industry's largest trade
group, the Biotechnology Industry Organization, welcomed the new guidelines,
saying member companies have always communicated extensively with the FDA.

For a number of years, biotechnology companies, their critics and the FDA
have wrestled behind the scenes over how the government should regulate
plant varieties that are being genetically engineered.

The prospect of bioengineered food crops has caused controversy in the
United States, and the idea has met strong consumer resistance in Europe.
That has made the American food industry concerned about its export markets.

In 2000, a genetically modified corn seed called Starlink mixed with other
varieties of corn and forced several food companies to recall products. A
worldwide drop in corn prices followed. Farmers and consumers sued Starlink
creator Aventis SA and other companies involved with its development and
distribution. The consumers said Starlink caused allergic reactions.

Mendelson said the new guidelines "are preparing us for the inevitable
situation where more Starlinks happen. Essentially, the FDA is acknowledging
that it will happen again."


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